FDA 483 - Zyno Medical LLC - February 15, 2026

During an FDA inspection conducted from January 19 to February 15, 2022, Zyno Medical LLC, a medical device manufacturer in Natick, MA, received a Form FDA 483 for significant quality system deficiencies. The inspection highlighted multiple areas requiring corrective action under the Federal Food, Drug, and Cosmetic Act. Key violations included inadequate procedures for design changes, particularly concerning durability, shelf-life, and packaging validation for Administration Sets after modifications, and improperly conducted usability assessments. The company also failed to adequately control non-conforming products, as evidenced by adjustable alarm volumes on infusion pumps despite known risks and an administration set with an incorrect inner tubing diameter leading to altered infusion rates without proper containment. Furthermore, Zyno Medical LLC's corrective and preventive action (CAPA) system was deficient, with numerous product complaints (e.g., flow rate issues, battery problems) not triggering CAPA initiation, and recurring defects lacking sustained corrective measures. Complaint handling procedures were also found inadequate, featuring incomplete investigations and a failure to investigate certain complaints when physical devices were unavailable. Supplier evaluation processes were not documented as required, and the firm repeatedly failed to submit timely Medical Device Reports (MDRs) for issues like reduced alarm volumes and drip chamber leaks, which was a repeated observation. The company has promised to correct all listed observations, necessitating a robust plan to bring its quality systems into compliance.